BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2142793 · Received June 20, 2011

    Report

    Report Number
    2017233-2011-00291
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 17, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THIS PT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE PHYSICIAN ATTEMPTED TO ADVANCE A CONTRALATERAL LEG COMPONENT; HOWEVER, THE DEVICE WAS REPORTEDLY GETTING CAUGHT ON THE CONTRALATERAL GATE OF THE TRUNK. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE AND ADVANCE THE SHEATH INTO THE GATE, THE DELIVERY CATHETER CAME OUT OF THE SHEATH WITH THE DEVICE MISSING. IT WAS REPORTED THAT THE DEVICE HAD DEPLOYED COVERING THE HYPOGASTRIC ARTERY. IT WAS REPORTED THE PHYSICIAN THEN IMPLANTED A CONTRALATERAL LEG COMPONENT TO BRIDGE THE GAP BETWEEN THE (B)(4) AND TRUNK-IPSILATERAL LEG COMPONENT. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES, INC WLG425 8897007

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R